EMA accepts Takeda application for subcutaneous Entyvio
Wednesday, April 03, 2019 12:00 AM

The European Medicines Agency (EMA) has accepted Takeda’s marketing authorisation application for its subcutaneous formulation of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s disease.

If approved, the drug would be the only maintenance therapy to offer the options of both intravenous or subcutaneous formulations across ulcerative colitis or Crohn’s disease.

The company proposes to make it available in both pre-filled syringe and pen options, helping provide greater choice in how patients receive therapy.

UCB's inflammatory arthritis drug gains FDA approval
Thursday, March 28, 2019 12:00 AM
The US Food and Drug Administration (FDA) has approved certolizumab pegol injection (Cimzia) for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first FDA-approved treatment for the inflammatory arthritis condition.

"Today's approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there [have] been no FDA-approved treatments until now," said Nikolay Nikolov, MD, associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

The FDA’s decision to approved was supported by efficacy results from a clinical trial of adult patients with non-radiographic axial spondyloarthritis with objective signs of inflammation— elevated C-reactive protein (CRP) levels and/or sacroiliitis on MRI. The trial included 317 adult patients who were randomized to certolizumab or placebo.
MiRus receives FDA Approval for First Medical Implant with New Superalloy- MoRe®
Wednesday, March 27, 2019 10:22 AM

ATLANTAMarch 27, 2019 /PRNewswire/ -- MiRus has received FDA 510(k) approval for the MoRe® based Europa™ Pedicle Screw System making it the first FDA approved medical device with this new class of implant material.  The Europa™ System received the 2018 Spine Technology Award at the NASS meeting for excellence and innovation in spine surgery.

MiRus has developed MoRe®, a proprietary molybdenum rhenium superalloy for medical implants, to provide an unprecedented combination of strength, ductility, durability, and biological safety that is unmatched by current materials.  MoRe® was designed to meet these criteria and is patent protected for use in all medical devices. 

The clinical needs of many patients remain unmet due to the limitations of current titanium, cobalt and iron based alloys originally developed more than 40 years ago. The MoRe® superalloy allows for the design of a new generation of smaller, stronger, more durable, and bio-friendly implants that will result in less soft tissue disruption, quicker recovery and better outcomes for patients.

Alcon announces $285M acquisition of PowerVision
Monday, March 18, 2019 12:00 AM

Novartis (NYSE:NVS) subsidiary Alcon said today that it acquired intraocular lens developer PowerVision for $285 million.

PowerVision is developing fluid-based intraocular lens implants that use the eye’s natural accommodating response to transport fluid in the implanted lens, Fort Worth, Texas-based Alcon said.

The fluid-based lens creates a continuously variable monofocal lens using the natural contractions of the eye’s muscles, Alcon said, allowing a patient to actively focus on objects in a style similar to a young eye’s crystalline lens.

ArunA Bio Appoints Al Medwar as Executive Vice President, Corporate and Commercial Development
Monday, March 18, 2019 12:00 AM

ATHENS, Ga – March 18, 2019 - ArunA Bio, a leader in the development of exosomes and exosome therapeutics for the treatment of neurodegenerative disorders, today announced the appointment of Al Medwar as Executive Vice President, Corporate and Commercial Development. Mr. Medwar joins the company and its leadership team contributing over 30 years of pharmaceutical industry experience.

Mr. Medwar joins recently appointed Chief Executive Officer, Dr. Mark A. Sirgo, and team as they focus on progressing ArunA’s neural exosome platform toward commercialization, including partnerships with companies in the CNS therapeutic area.

“I am pleased to have Al join the leadership team at ArunA Bio as we move aggressively to utilize our neural exosome platform to develop novel therapeutics to treat serious neurodegenerative disorders through both our internal pipeline and industry collaborations,” said Dr. Sirgo. “Al played a significant role in building BioDelivery Sciences into a fully integrated pharmaceutical company based on a platform technology. I look forward to successfully collaborating with Al again in this new and exciting venture.”

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